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news.Merck Serono, a division of Merck KGaA, has submitted a supplemental new drug application to the Japanese Ministry of Health, Labor and Welfare for a new indication of Gonal-f/Gonalef for ovulation induction in infertile women.
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The supplemental new drug application (sNDA) submission is supported by a Phase III single-blinded controlled study conducted in Japanese women with no or irregular ovulation, including polycystic ovary syndrome, which demonstrated the efficacy and safety of Gonal-f.
The sNDA submission file includes three presentations of Gonal-f in a prefilled pen, for ready-to-use self-injection, designed to improve treatment convenience and accurate dosage delivery (Gonal-f prefilled pen 300IU, 450IU, 900IU). The Gonal-f prefilled pen is specifically designed for infertility treatment and allows for multidose presentations. The sNDA file also includes Gonal-f in 75IU vial presentation.
Franck Latrille, executive vice president head of commercial international at Merck Serono, said: “The submission of Gonal-f in Japan for female infertility confirms our company’s commitment to provide patients with a full portfolio of infertility medications for every stage of the reproductive cycle. When approved, women in Japan would have access to the leading recombinant human follicle-stimulating hormone delivered in the only ready-to-use pre-filled pen available on the market, to help them build families.”